FDA.reportPublic FDA data

Medline

Primary DI
10888277385825
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
AR1291SRH
Catalog number
AR1291SRH
Device description
AR-1291S NITINOL SUTURING NDL,W/WIRE L
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGSRETENTION DEVICE, SUTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277385822PackageGS15In Commercial Distribution
10888277385825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827738582220888277385822
1088827738582510888277385825

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011629412V-CloseDRS Vascular, Inc.KGS2026-03-09
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
00850012846680SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007140LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00860007834233SUTUREGARD(R) Classic Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
00860007834240SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
10888277381766MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
10884450786199Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00860011629405Q-StopDRS Vascular, Inc.KGS2024-05-23
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
00630094199818Bioseal Inc.BIOSEALKGS2023-12-19
00630094199832Bioseal Inc.BIOSEALKGS2023-12-19
00630094199863Bioseal Inc.BIOSEALKGS2023-12-19
00630094199870Bioseal Inc.BIOSEALKGS2023-12-19
00630094199894Bioseal Inc.BIOSEALKGS2023-12-19
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
10630094199877Bioseal Inc.BIOSEALKGS2023-12-19
10630094199891Bioseal Inc.BIOSEALKGS2023-12-19
00630094199719Bioseal Inc.BIOSEALKGS2023-12-12
00630094199733Bioseal Inc.BIOSEALKGS2023-12-12
00630094199757Bioseal Inc.BIOSEALKGS2023-12-12
00630094199788Bioseal Inc.BIOSEALKGS2023-12-12