FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiCount Safety-Sponge
DI: 07613327405514
·
Model: 0611018180
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SurgiCount Safety-Sponge
- Primary DI
- 07613327405514
- Version / Model
- 0611018180
- Catalog Number
- 0611018180
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 3
- Public Version Date
- 2025-09-04
- Public Version Status
- Update
- Public Device Record Key
- 490dfa04-07e8-406a-9349-9e9dbd64c0d4
Device Description
Laparotomy Sponge
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GDY | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38496 | Radiopaque woven surgical sponge | A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327405515 | GS1 | pack | 40 | In Commercial Distribution | |
| Primary | 07613327405514 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 18.0 | Inch | |
| Length | 18.0 | Inch |