FDA UDI
In Commercial Distribution
🇺🇸 United States
ExpressBraid™ Graft Manipulation
DI: 00887868462566
·
Model: 110003464
·
Biomet Orthopedics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- ExpressBraid™ Graft Manipulation
- Primary DI
- 00887868462566
- Version / Model
- 110003464
- Catalog Number
- 110003464
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-07-19
- Public Version
- 1
- Public Version Date
- 2021-07-27
- Public Version Status
- New
- Public Device Record Key
- 1a6147b6-3934-4ed0-9ef6-f7dc1ef05dc9
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
- No
- 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 |
|---|---|---|---|---|
| GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13895 | Operative-site suture holder | A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 70887868462565 | GS1 | ||||
| Primary | 00887868462566 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3" Needle 38" |