GELITA-SPON® STANDARD
Basic Information
- Brand Name
- GELITA-SPON® STANDARD
- Primary DI
- 04260293133144
- Version / Model
- GS-325
- Company Name
- GELITA MEDICAL GmbH
- Labeler DUNS
- 330774063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-27
- Public Version
- 2
- Public Version Date
- 2023-12-14
- Public Version Status
- Update
- Public Device Record Key
- c0a2761e-c5dc-43ff-8e82-6ad767e281e0
- Distribution End Date
- 2023-12-12
Device Description
The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable. Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive capacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes. It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | 874.4780 | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48170 | Gelatin haemostatic agent | A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260293130143 | GS1 | Suture Box | 50 | Not in Commercial Distribution | 2023-12-12 |
| Primary | 04260293133144 | GS1 | ||||
| Package | 04260293137142 | GS1 | Transport Box | 12 | Not in Commercial Distribution | 2023-12-12 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Millimeter | |
| Height | 10 | Millimeter | |
| Depth | 10 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature, keep dry and away from sunlight