FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277383586
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
214001R
Catalog number
214001R
Device description
214001 @EXPRESSEW SUT NDL, FOR USE WITH
Published
2025-02-21
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
HWQPASSER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277383583PackageGS15In Commercial Distribution
10888277383586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827738358320888277383583
1088827738358610888277383586

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reprocessedA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a previously used single-use device that has been processed for an additional single-use patient application.

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
30197344020779MEDLINEDYND364951DYND3649512026-08-19
00080196549422MEDLINE486800PL486800PL2025-05-06
00197344024936MEDLINEMG5002MG50022024-03-13
00888277172015MEDLINESG310SG3102024-05-02
00888277327552MEDLINE486802PL486802PL2025-03-25
00888277327569MEDLINE486803PL486803PL2025-03-25
00888277327576MEDLINE486804PL486804PL2025-03-25
00888277415075MEDLINE486801PL486801PL2025-05-06
40080196294344MEDLINEMDR107003LMDR107003L2020-10-12
40080196320999MEDLINEMDR107002EMDR107002E2016-10-14
40080196321002MEDLINEMDR107003EMDR107003E2016-10-14
10889942000388NAMICDYNJCAPDYNJCAP2026-08-18
10889942000395NAMICDYNJCAPRDYNJCAPR2026-08-18
20197344158895MEDLINEMDT12080XLMDT12080XL2026-08-18
20197344158918MEDLINEMDT12081LMDT12081L2026-08-18
20197344158932MEDLINEMDT12083LMDT12083L2026-08-18
20197344158956MEDLINEMDT12083XLMDT12083XL2026-08-18
20197344158970MEDLINEMDT12084XLMDT12084XL2026-08-18
20197344158987MEDLINEMDT12085LMDT12085L2026-08-18
20197344159014MEDLINEMDT12086XLMDT12086XL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421878MillenniumAvalign Technologies, Inc.HWQ2026-07-23
00190776421885MillenniumAvalign Technologies, Inc.HWQ2026-07-23
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorTOBY ORTHOPAEDICSHWQ2026-04-22
00190776419998MillenniumAvalign Technologies, Inc.HWQ2026-04-15
00190776420000MillenniumAvalign Technologies, Inc.HWQ2026-04-15
10818674022207Suture passeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2026-04-14
10850067560170LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560187LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560194LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
04047844127964CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27