FDA UDI
In Commercial Distribution
🇺🇸 United States
PENDULOUS ABD LUMBO SUPPORT 2XL
DI: 00610570188239
·
Model: 08142966
·
Bird & Cronin, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PENDULOUS ABD LUMBO SUPPORT 2XL
- Primary DI
- 00610570188239
- Version / Model
- 08142966
- Company Name
- Bird & Cronin, LLC
- Labeler DUNS
- 045975349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 1
- Public Version Date
- 2022-09-07
- Public Version Status
- New
- Public Device Record Key
- a9779839-2a42-4443-909b-ed8caa259c01
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
- 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 |
|---|---|---|---|---|
| FSD | Binder, Abdominal | General Hospital | 880.5160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10003 | Abdominal binder, single-use | A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00610570188239 | GS1 |