FDA.reportPublic FDA data

RTMED

Primary DI
06971642804315
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
5/0 75cm Round Bodied 1/2 13mm
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
K232355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232355000Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.2024-01-16GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971642804315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642804315069716428043156971642804315

GMDN Terms#

Term, Definition table
TermDefinition
Silk sutureA 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.

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
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06