N/A
- Primary DI
- 10850003089017
- Brand
- N/A
- Company
- Optalmed, LLC
- Model
- 7002
- Catalog number
- 7002
- Device description
- Disposable Iris Retractors, 6 sets of 5 retractors
- Published
- 2021-02-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HOC | Clip, Iris Retractor |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HOC | Clip, Iris Retractor | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10850003089017 | Package | GS1 | 6 | In Commercial Distribution |
| 00850003089010 | Primary | GS1 | 0 | |
| 00850003089218 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10850003089017 | 10850003089017 | | |
| 00850003089010 | 00850003089010 | 850003089010 | 0850003089010 |
| 00850003089218 | 00850003089218 | 850003089218 | 0850003089218 |
GMDN Terms
| Term | Definition |
|---|
| Intraocular retractor, single-use | A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Caution |
| Special Storage Condition, Specify | 0 | 0 | Keep away from direct sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
Regulatory Flags
- DUNS number
- 037077801
- Device count
- 5
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- 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
- false
- Sterilization required before use
- false
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|---|
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| 00194613103095 | MSI Precision Specialty Instruments | Med Saver, Inc. | HOC | 2025-08-01 |
| 08058340220970 | Set of 4 Iris Retractors | AKTIVE SRL | HOC | 2024-01-11 |
| 08056477550502 | Set of 5 Iris Retractors | AKTIVE SRL | HOC | 2024-01-11 |
| 04049368058045 | N.A. | Geuder Aktiengesellschaft | HOC | 2023-07-06 |
| 04049368058199 | N.A. | Geuder Aktiengesellschaft | HOC | 2023-07-06 |
| 10845819000455 | OASIS® Iris Expander | OASIS MEDICAL, INC. | HOC | 2023-06-30 |
| 10845819005207 | Disposable Instruments | OASIS MEDICAL, INC. | HOC | 2023-06-30 |
| 00841668127377 | GRAETHER IRIS RETRACTOR STRAIGHT | KATENA PRODUCTS, INC. | HOC | 2022-12-07 |
| 00841668127384 | GRAETHER IRIS RETRACTOR ANGLED | KATENA PRODUCTS, INC. | HOC | 2022-12-07 |
| 00841668118887 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2022-11-16 |
| 00841668118894 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2022-11-16 |
| 00841668119747 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2022-11-16 |
| 00813059018397 | Diamatrix Ltd | Diamatrix | HOC | 2022-10-31 |
| 00840319726105 | Hayden Medical | Hayden Medical, Inc. | HOC | 2022-08-16 |
| 00886158007036 | Visitec® | Beaver-Visitec International, Inc. | HOC | 2022-01-26 |
| 00886158007043 | Visitec® I-Ring® | Beaver-Visitec International, Inc. | HOC | 2022-01-20 |
| 10850003089208 | N/A | Optalmed, LLC | HOC | 2021-03-10 |
| 10850003089086 | N/A | Optalmed, LLC | HOC | 2021-02-08 |
| 00850003089218 | N/A | Optalmed, LLC | HOC | 2021-02-01 |
| 00850003089225 | N/A | Optalmed, LLC | HOC | 2021-02-01 |
| 10850003089055 | N/A | Optalmed, LLC | HOC | 2021-02-01 |
| 18717872009640 | Iris Retractor. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HOC | 2021-01-07 |
| 18717872009657 | Iris Retractor. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HOC | 2021-01-07 |
| 00810799031990 | Stephens Instruments | KRISHNA IMPORTS INC | HOC | 2020-09-22 |
| 00841668103685 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2020-09-14 |
| 00841668103692 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2020-09-14 |
| 00841668103708 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2020-09-14 |
| 00841668103715 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2020-09-14 |
| 00841668103722 | Iris Retractor | KATENA PRODUCTS, INC. | HOC | 2020-09-14 |