WELLBRACE
- Primary DI
- 07798094540115
- Brand
- WELLBRACE
- Company
- PANTYMED S.A.
- Model
- 1104-501N U L
- Device description
- CABESTRILLO DOBLE SUJECION - W - L
- Published
- 2024-01-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| ILI | Sling, Arm |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07798094540115 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07798094540115 | 07798094540115 | 7798094540115 |
GMDN Terms
| Term | Definition |
|---|---|
| Limb-worn device hygienic cover | A device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 971365986
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07798094540023 | WELLBRACE | 1601-AR U U | 2024-01-08 | |
| 07798128673581 | WELLBRACE | 1215-ANR U L | 2024-02-29 | |
| 07798094540160 | WELLBRACE | 1205-2400R U S | 2024-02-28 | |
| 07798094540177 | WELLBRACE | 1205-2400R U M | 2024-02-28 | |
| 07798094540184 | WELLBRACE | 1205-2400R U L | 2024-02-28 | |
| 07798094540191 | WELLBRACE | 1205-2400R U XL | 2024-02-28 | |
| 07798094540207 | WELLBRACE | 1205-2400R U 2XL | 2024-02-28 | |
| 07798094540269 | WELLBRACE | 1205-2800R U S | 2024-02-28 | |
| 07798094540276 | WELLBRACE | 1205-2800R U M | 2024-02-28 | |
| 07798094540283 | WELLBRACE | 1205-2800R U L | 2024-02-28 | |
| 07798094540290 | WELLBRACE | 1205-2800R U XL | 2024-02-28 | |
| 07798094540306 | WELLBRACE | 1205-2800R U 2XL | 2024-02-28 | |
| 07798094540313 | WELLBRACE | 1205-2800T U S | 2024-02-28 | |
| 07798094540320 | WELLBRACE | 1205-2800T U M | 2024-02-28 | |
| 07798094540337 | WELLBRACE | 1205-2800T U L | 2024-02-28 | |
| 07798094540344 | WELLBRACE | 1205-2800T U XL | 2024-02-28 | |
| 07798094540351 | WELLBRACE | 1205-2800T U 2XL | 2024-02-28 | |
| 07798094540368 | WELLBRACE | 1205-3200R U S | 2024-02-28 | |
| 07798094540924 | WELLBRACE | 1205-640 U S | 2024-02-28 | |
| 07798094540931 | WELLBRACE | 1205-640 U M | 2024-02-28 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 16974500613613 | Arm Sling | GCMEDICA ENTERPRISE LTD.(WUXI) | ILI | 2025-12-12 |
| 16974500613620 | Arm Sling | GCMEDICA ENTERPRISE LTD.(WUXI) | ILI | 2025-12-12 |
| 00810113683027 | Shoulder Brace with Airplane Kit | Manamed, Inc. | ILI | 2025-09-19 |
| 00810113683034 | Shoulder Brace with Airplane Kit LOGO | Manamed, Inc. | ILI | 2025-09-19 |
| 00190446660354 | PROCARE | DJO, LLC | ILI | 2025-07-14 |
| 50749756397846 | DeRoyal | DEROYAL INDUSTRIES, INC. | ILI | 2025-02-27 |
| 00749756397285 | DeRoyal | DEROYAL INDUSTRIES, INC. | ILI | 2025-02-13 |
| 00840314811097 | UNIV ARM SLING W/FOAM STRAP ADULT | Hausmann Enterprises, LLC | ILI | 2025-01-01 |
| 10810113576944 | CoreTech | VIVE HEALTH LLC | ILI | 2024-06-10 |
| 10057475611023 | BIOS Living | Thermor Ltd | ILI | 2024-05-23 |
| 00888912014366 | DONJOY | DJO, LLC | ILI | 2024-02-27 |
| 07798094540061 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540078 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540085 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540092 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540108 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540511 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540528 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540535 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094540542 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094541105 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094541624 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547770 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547787 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547794 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547879 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547886 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798094547893 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798128672034 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |
| 07798128672041 | WELLBRACE | PANTYMED S.A. | ILI | 2024-01-05 |