FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiMend®
DI: 10381780112969
·
Model: 606-005-004
·
TEI BIOSCIENCES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SurgiMend®
- Primary DI
- 10381780112969
- Version / Model
- 606-005-004
- Catalog Number
- 606-005-004
- Company Name
- TEI BIOSCIENCES INC.
- Labeler DUNS
- 796253292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-14
- Public Version
- 9
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 77462844-ea11-49ff-b235-28388ef0db6e
Device Description
SurgiMend® Thin Collagen Matrix for Soft Tissue Reconstruction
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 |
|---|---|---|---|---|
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61218 | Extra-gynaecological surgical mesh, collagen, non-bioabsorbable | A non-bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde). Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780112969 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083898 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 x 15 x (0.40 - 1.00) cm x cm x mm |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius