FDA.reportPublic FDA data

CoLag

Primary DI
00810021866963
Brand
CoLag
Company
In2Bones USA, LLC
Model
P06 N0004
Catalog number
P06 N0004
Device description
CoLag 2.0-4.0 Reusable Instrument Set, NS
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170518000In2Bones Fracture and Correction SystemIn2bones USA, LLC2017-07-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021866963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021866963008100218669638100218669630810021866963

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
079700711
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100218611735MSP06 N0241P06 N02412019-06-14
008179060297345MSP06 N0261P06 N02612019-06-14
008179060297415MSP06 N0271P06 N02712019-06-14
008179060297585MSP06 N0281P06 N02812019-06-14
008179060297655MSP06 N0291P06 N02912019-06-14
00817906027921CoLinkP04 N0012P04 N00122018-10-22
00817906027945CoLinkP04 N0101P04 N01012018-10-22
00817906027952CoLinkP04 N0102P04 N01022018-10-22
00817906027969CoLinkP04 N0103P04 N01032018-10-22
00817906027976CoLinkP04 N0104P04 N01042018-10-22
00817906027983CoLinkP04 N0105P04 N01052018-10-22
00817906027990CoLinkP04 N0131P04 N01312018-10-22
00817906028003CoLinkP04 N0132P04 N01322018-10-22
00817906028010CoLinkP04 N0141P04 N01412018-10-22
00817906028027CoLinkP04 N0142P04 N01422018-10-22
00817906028034CoLinkP04 N0151P04 N01512018-10-22
00817906028041CoLinkP04 N0152P04 N01522018-10-22
00817906028058CoLinkP04 N0161P04 N01612018-10-22
00817906028065CoLinkP04 N0171P04 N01712018-10-22
00817906028072CoLinkP04 N0172P04 N01722018-10-22

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Primary DI, Brand, Company table
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10806378116810ACUMEDAcumed LLCFSM2026-08-18
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10806378116841ACUMEDAcumed LLCFSM2026-08-18
10806378116858ACUMEDAcumed LLCFSM2026-08-18
G8791062750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
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G879107241L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072790DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
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G879SC07S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
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G879SC20A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC21N0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
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