FDA.reportPublic FDA data

Surgical Kit Grommet - Large (2pk)

Primary DI
10841307123644
Brand
Surgical Kit Grommet - Large (2pk)
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
SKG-L
Catalog number
SKG-L
Device description
Grommet -L
Published
2017-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307123644PrimaryGS10
00841307123647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084130712364410841307123644
00841307123647008413071236478413071236470841307123647

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-649-6425customerservice@implantdirect.com

Regulatory Flags#

DUNS number
868856969
Device count
2
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841307130284Ball Abutment Housing1000-811000-812024-03-12
10841307130291Ball Abutment Nylon Liner1000-821000-822024-03-12
10841307120100Ball Abutment Housing & Liner1000-881000-882015-12-29
10841307122463DirectOss™DXCA102005DXCA1020052016-08-31
10841307122470DirectOss™DXCA102010DXCA1020102016-08-31
10841307122487DirectOss™DXCA102015SDXCA102015S2016-08-31
10841307122494DirectOss™DXCA102020DXCA1020202016-08-31
10841307122500DirectOss™DXCA102025DXCA1020252016-08-31
10841307122517DirectOss™DXCA251005DXCA2510052016-08-31
10841307122524DirectOss™DXCA251005SDXCA251005S2016-08-31
10841307122531DirectOss™DXCA251010DXCA2510102016-08-31
10841307122548DirectOss™DXCA251010SDXCA251010S2016-08-31
10841307122555DirectOss™DXCA251020DXCA2510202016-08-31
10841307122562DirectOss™DXCA251025DXCA2510252016-08-31
10841307122579DirectOss™DXCA251025SDXCA251025S2016-08-31
10841307119234Stainless Steel RachetRR2015-12-29
10841307123651Surgical Kit Grommet - Medium (2pk)SKG-MSKG-M2017-06-23
10841307123668Surgical Kit Grommet - Small (2pk)SKG-SSKG-S2017-06-23
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoDA6530-61SDA6530-61S2025-10-31
10841307135791Simply Iconic™ / InterActive™ Healing Collar6530-176530-172026-01-05

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