U.S. IOL, Inc.

Primary DI
00814106016144
Brand
U.S. IOL, Inc.
Company
U.S. IOL, INC.
Model
US-8002LZS
Catalog number
US-8002LZS
Device description
8/0 Micro Spatula, Double-Armed Silk Suture
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAPSUTURE, NONABSORBABLE, SILK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024091000SILK SUTURESAurolab2003-02-28GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814106016151PackageGS112In Commercial Distribution
00814106016144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814106016151008141060161518141060161510814106016151
00814106016144008141060161448141060161440814106016144

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture"A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a ""non-bioabsorbable"" material, it may be digested by proteolysis after an extended period of time. This is a single-use device."

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(859)259-4925usiol@aol.com

Regulatory Flags#

DUNS number
604739490
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814106015949U.S. IOL, Inc.US-6002-LZNUS-6002-LZN2020-09-22
00814106015963U.S. IOL, Inc.US-7002-LZNUS-7002-LZN2020-09-22
00814106015987U.S. IOL, Inc.US-8002-LZNUS-8002-LZN2020-09-22
00814106016007U.S. IOL, Inc.US-9002-LZNUS-9002-LZN2020-09-22
00814106016021U.S. IOL, Inc.US-1002LZNUS-1002LZN2020-09-22
00814106016045U.S. IOL, Inc.US-5002LZNUS-5002LZN2020-09-22
00814106016069U.S. IOL, Inc.US-6002LZVUS-6002LZV2020-09-22
00814106016083U.S. IOL, Inc.US-7002LZVUS-7002LZV2020-09-22
00814106016106U.S. IOL, Inc.US-8002LZVUS-8002LZV2020-09-22
00814106016120U.S. IOL, Inc.US-9002LZVUS-9002LZV2020-09-22
00803878044721U.S. IOL, Inc.U-BLUEU-BLUE2020-09-22
00814106015956U.S. IOL, Inc.US-6002-LZNUS-6002-LZN2020-09-22
00814106015970U.S. IOL, Inc.US-7002-LZNUS-7002-LZN2020-09-22
00814106015994U.S. IOL, Inc.US-8002-LZNUS-8002-LZN2020-09-22
00814106016014U.S. IOL, Inc.US-9002-LZNUS-9002-LZN2020-09-22
00814106016038U.S. IOL, Inc.US-1002LZNUS-1002LZN2020-09-22
00814106016052U.S. IOL, Inc.US-5002LZNUS-5002LZN2020-09-22
00814106016076U.S. IOL, Inc.US-6002LZVUS-6002LZV2020-09-22
00814106016090U.S. IOL, Inc.US-7002LZVUS-7002LZV2020-09-22
00814106016113U.S. IOL, Inc.US-8002LZVUS-8002LZV2020-09-22

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