FDA.reportPublic FDA data

RTMED

Primary DI
06971642807828
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
2-0 75cm 3/8 Reverse Cutting 26mm
Published
2024-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230746000Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.2023-09-14GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971642807828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642807828069716428078286971642807828

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550402542
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971642806500RTMED6-0 Cutting 3/8 9mm 45cm 2024-01-05
06971642806517RTMED6-0 Round Bodied 1/2 10mm 45cm2024-01-05
06971642806524RTMED6-0 Round Bodied 1/2 13mm 75cm2024-01-05
06971642806531RTMED6-0 Without Needle 150cm2024-01-05
06971642806548RTMED5-0 Cutting 3/8 12mm 75cm2024-01-05
06971642806555RTMED5-0 Round Bodied 1/2 13mm 75cm2024-01-05
06971642806562RTMED5-0 Without Needle 150cm 2024-01-05
06971642806579RTMED4-0 Reverse Cutting 3/8 16mm 75cm2024-01-05
06971642806586RTMED4-0 Reverse Cutting 3/8 19mm 75cm2024-01-05
06971642806593RTMED4-0 Round Bodied 1/2 20mm 75cm2024-01-05
06971642806609RTMED4-0 Without Needle 150cm 2024-01-05
06971642806616RTMED3-0 Cutting 3/8 19mm 75cm2024-01-05
06971642806623RTMED3-0 Cutting 3/8 24mm 75cm2024-01-05
06971642806630RTMED3-0 Reverse Cutting 3/8 26mm 75cm2024-01-05
06971642806647RTMED3-0 Round Bodied 1/2 20mm 75cm2024-01-05
06971642806654RTMED3-0 Round Bodied 1/2 24mm 75cm2024-01-05
06971642806661RTMED3-0 Without Needle 150cm 2024-01-05
06971642806678RTMED2-0 Reverse Cutting 3/8 26mm 75cm2024-01-05
06971642806685RTMED2-0 Cutting 3/8 30mm 75cm2024-01-05
06971642806692RTMED2-0 Cutting 3/8 35mm 75cm2024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07