FDA.reportPublic FDA data

RTMED

Primary DI
06971642806845
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
2# Cutting 3/8 40mm 75cm
Published
2024-01-05
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231183000Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd.2023-08-25GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971642806845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642806845069716428068456971642806845

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24