FDA UDI
In Commercial Distribution
🇺🇸 United States
AmerisourceBergen
DI: 00368001111027
·
Model: 11102
·
BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- AmerisourceBergen
- Primary DI
- 00368001111027
- Version / Model
- 11102
- Company Name
- BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Labeler DUNS
- 985523874
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-11-02
- Public Version
- 1
- Public Version Date
- 2021-11-10
- Public Version Status
- New
- Public Device Record Key
- 3ac4fb5d-c34a-49e5-a79f-9d08c36d5d36
Device Description
X-Ray Detectable Sponges 4in X 4in Non-Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | 60368001111029 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00368001111027 | GS1 | ||||
| Unit of Use | 80368001111023 | GS1 |