Apdyne
- Primary DI
- 10385640070123
- Brand
- Apdyne
- Company
- Summit Medical, Inc.
- Model
- 15-06
- Published
- 2022-06-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| KCJ | Applicator, Ent |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KCJ | Applicator, Ent | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10385640070123 | Package | GS1 | 6 | In Commercial Distribution |
| 00385640070126 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10385640070123 | 10385640070123 | | |
| 00385640070126 | 00385640070126 | 385640070126 | 0385640070126 |
GMDN Terms
| Term | Definition |
|---|
| General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. |
Regulatory Flags
- DUNS number
- 965484699
- Device count
- 1
- 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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00757770410972 | Bausch + Lomb | Bausch & Lomb Incorporated | KCJ | 2025-07-29 |
| 00757770420179 | Bausch + Lomb | Bausch & Lomb Incorporated | KCJ | 2025-07-29 |
| 00757770420766 | Bausch + Lomb | Bausch & Lomb Incorporated | KCJ | 2025-07-29 |
| 00757770427383 | Bausch + Lomb | Bausch & Lomb Incorporated | KCJ | 2025-07-29 |
| 00850027492698 | Naväge | Rhinosystems, Inc. | KCJ | 2024-11-15 |
| 00887482037898 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KCJ | 2024-08-15 |
| 00840183517489 | BR Surgical, LLC | BR Surgical, LLC | KCJ | 2024-05-29 |
| 04055207009734 | NA | Richard Wolf GmbH | KCJ | 2024-05-21 |
| 00850022483073 | Saline Noze Mist | Dr. Noze Best | KCJ | 2024-02-05 |
| G586E1032750 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E1035960 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032250 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032270 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032290 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032750 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032770 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91032790 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91035460 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| G586E91035960 | Novo Surgical | NOVO SURGICAL, INC. | KCJ | 2023-12-18 |
| 00842331192524 | Novo Surgical Inc. | NOVO SURGICAL, INC. | KCJ | 2023-12-07 |
| 25060259070420 | Sigma Swab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 45060259070486 | Sigma Swab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 25060259070857 | Dryswab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 55060259070988 | Dryswab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 55060259070995 | Dryswab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 15060259073127 | Dryswab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 25060259073131 | Dryswab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | KCJ | 2023-10-05 |
| 00705928002043 | NeilMed Sinus Rinse | NEILMED PHARMACEUTICALS, INC. | KCJ | 2023-03-02 |
| 00705928003002 | NeilMed Sinus Rinse | NEILMED PHARMACEUTICALS, INC. | KCJ | 2023-03-02 |
| 00705928003101 | Sinus Rinse Kit | NEILMED PHARMACEUTICALS, INC. | KCJ | 2023-03-02 |