CARDINAL HEALTH
- Primary DI
- 50197106447183
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- SBAHFLBMIA
- Catalog number
- SBAHFLBMIA
- Device description
- LAPAROSCOPIC BARIATRIC PACK
- Published
- 2023-11-09
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| FDA | Enteroscope and accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FDA | Enteroscope And Accessories | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 50197106447183 | Package | GS1 | 2 | In Commercial Distribution |
| 10197106447185 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 50197106447183 | 50197106447183 |
| 10197106447185 | 10197106447185 |
GMDN Terms
| Term | Definition |
|---|---|
| General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
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|---|---|---|---|---|
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| 20192253017615 | Medi-Trace Cadence | 22661PC | 22661PC | 2021-07-29 |
| 20192253019992 | Kendall | 33547T | 33547T-- | 2026-05-26 |
| 20885380136617 | CARDINAL HEALTH | N8830 | N8830 | 2019-02-07 |
| 20885380136624 | CARDINAL HEALTH | N8831 | N8831 | 2019-02-07 |
| 20885380136631 | CARDINAL HEALTH | N8832 | N8832 | 2019-02-07 |
| 20885380168069 | CARDINAL HEALTH | C3660PPL | C3660PPL | 2019-04-30 |
| 10192253045093 | Kendall | MK00175 | MK00175 | 2023-06-15 |
| 10192253013016 | Argyle | 8888750018 | 8888750018 | 2022-10-26 |
| 10192253013023 | Argyle | 8888750513 | 8888750513 | 2022-10-26 |
| 10198956056497 | CARDINAL HEALTH | PN69MSGAD | PN69MSGAD | 2026-05-25 |
| 10198956057005 | CARDINAL HEALTH | SBACGDPMED | SBACGDPMED | 2026-05-25 |
| 10198956221161 | CARDINAL HEALTH | SOP29PLCCY | SOP29PLCCY | 2026-05-25 |
| 10198956253773 | CARDINAL HEALTH | SOP56TKTCC | SOP56TKTCC | 2026-05-25 |
| 10198956257610 | CARDINAL HEALTH | SOPOCTKLHK | SOPOCTKLHK | 2026-05-25 |
| 10198956258730 | CARDINAL HEALTH | AMN4Q8277C | AMN4Q8277C | 2026-05-25 |
| 10198956291812 | CARDINAL HEALTH | SOP4FKPWFB | SOP4FKPWFB | 2026-05-25 |
| 10198956300316 | CARDINAL HEALTH | 34-2071H | 34-2071H | 2026-05-25 |
| 10198956321632 | CARDINAL HEALTH | SOPCGKHAUC | SOPCGKHAUC | 2026-05-25 |
| 10198956325487 | CARDINAL HEALTH | PO43LEUNC | PO43LEUNC | 2026-05-25 |
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| 50197106523641 | CARDINAL HEALTH | Cardinal Health 200, LLC | FDA | 2024-01-24 |
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| 70075289122810 | ProWorks | TRANZONIC COMPANIES, THE | FDA | 2020-04-02 |
| 00811503033316 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | FDA | 2019-03-27 |
| 10811503033306 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | FDA | 2019-03-27 |
| J021300030020 | TG-98 LM Synea 400 | W & H Dentalwerk Bürmoos GmbH | FDA | 2018-08-31 |
| 00840916123130 | Zeua | SPINAL ELEMENTS | FDA | 2017-08-06 |
| 00858641006208 | Set, Administration, Intravascular | LIFE SCIENCE OUTSOURCING, INC. | FDA | 2017-03-29 |
| 04547410330243 | FUJIFILM | FUJIFILM CORPORATION | FDA | 2016-12-14 |
| 04547410330953 | FUJIFILM | FUJIFILM CORPORATION | FDA | 2016-12-14 |
| 04547410330960 | FUJIFILM | FUJIFILM CORPORATION | FDA | 2016-12-14 |
| 04547410331646 | FUJIFILM | FUJIFILM CORPORATION | FDA | 2016-12-14 |
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| 04953170239533 | BALLOON CONTROL UNIT | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |
| 04953170239564 | OBCU REMOTE CONTROLLER | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |
| 04953170303043 | ENDOSCOPE POSITION DETECTING UNIT | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |
| 04953170305757 | CLV-UPD CABLE | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |
| 04953170331145 | ENDOSCOPE POSITION DETECTING UNIT | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |
| 04953170339943 | EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | FDA | 2016-09-21 |