FDA.reportPublic FDA data

Fastloop™ Green

Primary DI
00854629006857
Brand
Fastloop™ Green
Company
DUNAMIS MEDICAL, LLC
Model
DFX24SLG
Device description
Polyester Suture Loop Green with Needle
Published
2022-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K192490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192490000Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical2020-03-30GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854629006854PrimaryGS10
00854629006857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085462900685410854629006854
00854629006857008546290068578546290068570854629006857

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

Contacts#

Phone, Email table
PhoneEmail
877.454.2186info@dunamismedical.com

Regulatory Flags#

DUNS number
079471560
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854629006847Fastloop™ WhiteDFX24SLW2022-03-03
10854629006854Fastloop™ GreenDFX24SLG2022-03-03
00850052601317Olecranon Transporter™ Repair KitOL-2000OL-20002025-04-29
00850052601294Force DFX Suture Loop -Xtreme™DFX34XSLDFX0034S2025-04-10
40854629006916Orca™ Xtreme Knotless ButtonAB-6900AB-69002024-01-31
00854629006956Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit 3500-00-00013500-00-00012023-07-31
00850052601263Constrictor® Mini 2.0 Syndesmosis Repair Kit AB-3700AB-37002024-09-19
00850052601270Constrictor® 2.0 Syndesmosis Repair Kit AB-2700AB-27002024-09-19
00854629006789Constrictor® Mini Syndesmosis Repair Kit AB-3200AB-32002024-09-19
00850052601256Micro Constrictor ®X Repair KitAB-8700AB-87002024-09-19
00850052601249Orca™ Implantation Kit AB-6250AB-62502024-06-20
00850052601072Hallux GuideDU1000DU10002024-06-10
00850052601089CMC SpacerDNS000/DNS001DNS000/DNS0012024-06-10
00850052601096CMC GuideDU3000DU30002024-06-10
00850052601157Threaded Driver 100161010016102024-06-10
00850052601232Micro Constrictor® Implantation Kit AB-8250AB-69502024-06-10
00850052601225Orca Xtreme ™ Kit Knotless ButtonAB-6925AB-69252024-03-14
00850052601218Orca™ Xtreme Implantation Kit AB-6950AB-69502024-02-13
00854629006147PunchTac 3mm Anchor PEEKDFX0028ADFX0028A2017-04-11
00854629006161PunchTac 3.5mm Anchor PEEKDFX0029ADFX0029A2017-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
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