FDA UDI
In Commercial Distribution
🇺🇸 United States
SBH
DI: 00850068304059
·
Model: Single Use - 3721036-S
·
SBH Surgical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SBH
- Primary DI
- 00850068304059
- Version / Model
- Single Use - 3721036-S
- Catalog Number
- SBH 3721036-S
- Company Name
- SBH Surgical
- Labeler DUNS
- 096823436
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 1
- Public Version Date
- 2024-10-14
- Public Version Status
- New
- Public Device Record Key
- 355c18d9-242d-4909-9e5c-e94953d9e4a9
Device Description
Sterile Single-Use, Alligator Forceps, Very Fine, .9mm x 4.5mm, Straight, 3 1/8”
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63658 | Surgical soft-tissue manipulation forceps, alligator, single-use | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures, typically during ear/nose/throat (ENT) surgery; it is not intended for insertion through an endoscope, nor into the eye and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850068304059 | GS1 |
Customer Contacts
- Phone
- 9493053300
- [email protected]