PERFORMANCE HEALTH
- Primary DI
- 00840216112230
- Brand
- PERFORMANCE HEALTH
- Company
- ASP GLOBAL, LLC
- Model
- A34916
- Device description
- R-Stretch Elasticized Loop, White, 5/8" x 10 yd. (1.6cm x 9m)
- Published
- 2022-05-11
- 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 |
|---|---|
| IPM | Cover, Limb |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IPM | Cover, Limb | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840216112230 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840216112230 | 00840216112230 | 840216112230 | 0840216112230 |
GMDN Terms
| Term | Definition |
|---|---|
| Splint padding/strapping material | A sheet of flexible multi-layered material intended to be used to pad or strap a splint to an appendage, typically for use on a paediatric patient. It is made of layers of cotton, nylon and non-latex rubber (e.g., neoprene) and can be cut to a required size. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 080361159
- 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
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00840216128262 | ASP GLOBAL | EGT305 | 2025-11-20 | |
| 00840216128286 | ASP GLOBAL | EGT307 | 2025-11-20 | |
| 00840216128804 | ASP GLOBAL PRIMO | AFTS01 | 2025-06-30 | |
| 00840216128279 | ASP GLOBAL | EGT306 | 2025-06-17 | |
| 00840216128293 | ASP GLOBAL | EGT308 | 2025-06-17 | |
| 00840216128842 | CARDINAL HEALTH | AD6X10BILH | 2025-06-17 | |
| 00840216128606 | LAPCORP | LC4X6EZQ | 2025-05-13 | |
| 00840216128613 | LAPCORP | LC9X12MTL | 2025-05-13 | |
| 00840216128163 | QUEST DIAGNOSTICS | QD6.75X11AD | 2024-11-22 | |
| 00840216127753 | ASP MEDICAL | MRT800 | 2024-09-12 | |
| 00840216128033 | ASP MEDICAL | MRACUP1 | 2024-09-12 | |
| 20840216127566 | PRIMO | AFTMATT | 2024-08-12 | |
| 00840216120808 | PRIMO | GGS3660TBH-K | 2024-03-05 | |
| 00840216120853 | PRIMO | GGS5670TBH-K | 2024-03-05 | |
| 00840216121898 | PRIMO | GGTS14 | 2024-03-05 | |
| 00840216124509 | PRIMO | GGTS13-K | 2024-03-05 | |
| 00840216124516 | PRIMO | GGTS14-5-K | 2024-03-05 | |
| 00840216122697 | PRIMO | AFPUMP | 2024-03-01 | |
| 00840216125124 | PRIMO | HB200 | 2024-03-01 | |
| 00840216125131 | PRIMO | HB200B | 2024-03-01 |
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|---|---|---|---|---|
| 20809160489885 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | IPM | 2025-08-01 |
| 20809160489465 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | IPM | 2025-07-31 |
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