FDA UDI
In Commercial Distribution
🇺🇸 United States
BandGrip® Micro-Anchor® Skin Closure
DI: 00850010207193
·
Model: BG1000-F
·
BANDGRIP INC.
Product Codes
4
GMDN Terms
1
Identifiers
3
Pkg Device Count
36
Basic Information
- Brand Name
- BandGrip® Micro-Anchor® Skin Closure
- Primary DI
- 00850010207193
- Version / Model
- BG1000-F
- Catalog Number
- BG1000F
- Company Name
- BANDGRIP INC.
- Labeler DUNS
- 080545512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 1
- Public Version Date
- 2021-03-09
- Public Version Status
- New
- Public Device Record Key
- 4b5e38fa-99a5-4f3e-b1d8-ba36c44f5690
Device Description
5 cm x 5 cm, Perforated, 1 closure/pouch
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDT | STAPLE, REMOVABLE (SKIN) | General, Plastic Surgery | 878.4760 | 1 |
| FZQ | CLIP, REMOVABLE (SKIN) | General, Plastic Surgery | 878.4320 | 1 |
| MKY | SYSTEM, SKIN CLOSURE | General, Plastic Surgery | 878.4320 | 1 |
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850010207190 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00850010207193 | GS1 | ||||
| Unit of Use | 00850010207186 | GS1 |
Customer Contacts
- Phone
- +1(844)968-6322
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 cm x 5 cm, Perforated, 1 closure/pouch | ||
| Width | 5 | Centimeter | |
| Length | 5 | Centimeter |