FDA.report

Prosthetic Kit Tray (empty)

Primary DI
10841307124696
Brand
Prosthetic Kit Tray (empty)
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
PK-E
Catalog number
PK-E
Published
2019-09-18
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
false

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841307124696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084130712469610841307124696

GMDN Terms

TermDefinition
Medical device integration rackA device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-649-6425customerservice@implantdirect.com

Regulatory Flags

DUNS number
868856969
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10841307135791Simply Iconic™ / InterActive™ Healing Collar6530-176530-172026-01-05
10841307135807Simply Iconic™ / InterActive™ Healing Collar6530-17N6530-17N2026-01-05
10841307135814Simply Iconic™ / InterActive™ Healing Collar6534-176534-172026-01-05
10841307135821Simply Iconic™ / InterActive™ Healing Collar6534-17N6534-17N2026-01-05
10841307135838Simply Iconic™ / InterActive™ Healing Collar6534-17W6534-17W2026-01-05
10841307135340Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewDA1000-20SDA1000-20S2025-10-31
10841307135357Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarDA8730-61SDA8730-61S2025-10-31
10841307135364Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarDA8730-62SDA8730-62S2025-10-31
10841307135371Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarDA8730-63SDA8730-63S2025-10-31
10841307135388Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarDA8730-64SDA8730-64S2025-10-31
10841307135395Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarDA8730-65SDA8730-65S2025-10-31
10841307135401Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarDA8730-61-17SDA8730-61-17S2025-10-31
10841307135418Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarDA8730-62-17SDA8730-62-17S2025-10-31
10841307135425Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarDA8730-61-30SDA8730-61-30S2025-10-31
10841307135432Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarDA8730-62-30SDA8730-62-30S2025-10-31
10841307135449Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewDA1000-01SGDA1000-01SG2025-10-31
10841307135456Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarDA8735-61SDA8735-61S2025-10-31
10841307135463Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarDA8735-62SDA8735-62S2025-10-31
10841307135470Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarDA8735-63SDA8735-63S2025-10-31
10841307135487Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarDA8735-64SDA8735-64S2025-10-31