AVID TruCustom
- Primary DI
- 20809160057794
- Brand
- AVID TruCustom
- Company
- AVID MEDICAL, INC.
- Model
- OPTH006_0001
- Published
- 2016-09-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| HMT | Drape, patient, ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20809160057794 | Package | GS1 | 13 | Not in Commercial Distribution |
| 10809160057797 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20809160057794 | 20809160057794 |
| 10809160057797 | 10809160057797 |
GMDN Terms
| Term | Definition |
|---|---|
| Ophthalmic surgical drape | A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide |
Regulatory Flags
- DUNS number
- 015623119
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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|---|---|---|---|---|
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| 20809160517243 | Halyard | AVMD050-01_0007 | AVMD050-01 | 2026-03-24 |
| 20809160517250 | Halyard | USAR017-12_0006 | USAR017-12 | 2026-03-24 |
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| 20809160517120 | Halyard | KAFB027_0010 | KAFB027 | 2026-03-23 |
| 20809160517137 | Halyard | UFCF010-03_0008 | UFCF010-03 | 2026-03-23 |
| 20809160517144 | Halyard | VMCD018-11_0004 | VMCD018-11 | 2026-03-23 |
| 20809160517151 | Halyard | VAML019-09_0004 | VAML019-09 | 2026-03-23 |
| 20809160517168 | Halyard | NHJV7000-20_0008 | NHJV7000-20 | 2026-03-23 |
| 20809160517175 | Halyard | EAMC109-06_0008 | EAMC109-06 | 2026-03-23 |
| 20809160517182 | Halyard | OSTK19-01_0007 | OSTK19-01 | 2026-03-23 |
| 20809160517199 | Halyard | DUAC16-01_0010 | DUAC16-01 | 2026-03-23 |
| 20809160517205 | Halyard | VAML058_0017 | VAML058 | 2026-03-23 |
| 20809160517212 | Halyard | SAMT100-12_0007 | SAMT100-12 | 2026-03-23 |
| 20809160517229 | Halyard | ESED52-01_0013 | ESED52-01 | 2026-03-23 |
| 20809160516734 | Halyard | LIFE0156-03_0008 | LIFE0156-03 | 2026-03-20 |
| 20809160516741 | Halyard | WERP43-01_0002 | WERP43-01 | 2026-03-20 |
| 20809160516758 | Halyard | WEGL20-01_0004 | WEGL20-01 | 2026-03-20 |
| 20809160516765 | Halyard | WEHY18-01_0002 | WEHY18-01 | 2026-03-20 |
| 20809160516772 | Halyard | WEGB22-01_0002 | WEGB22-01 | 2026-03-20 |
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| 50885380169197 | CONVERTORS | Cardinal Health 200, LLC | HMT | 2019-01-21 |