SLEEVE
- Primary DI
- 00840331272017
- Brand
- SLEEVE
- Company
- BURLINGTON MEDICAL, LLC
- Model
- U8SL3-LG
- Device description
- Sleeve - Slip On .25mm Xenolite 800 NL Size Large
- Published
- 2022-09-22
- 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
Product Codes
| Code | Name |
|---|
| KPY | Shield, Protective, Personnel |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KPY | Shield, Protective, Personnel | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840331272017 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Surgical sleeve cover | A forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device. |
Regulatory Flags
- DUNS number
- 083381202
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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