SUTUMED

Basic Information

• Brand Name: SUTUMED
• Primary DI: 07757093001492
• Version / Model: SDAG020MR260
• Catalog Number: SDAG020MR260
• Company Name: Unilene S.A.C.
• Labeler DUNS: 934900072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-14
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 2ba32d42-8839-402a-a57e-c584fef93234

Device Description

POLYGLACTIN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAN	SUTURE, ABSORBABLE, SYNTHETIC	General, Plastic Surgery	878.4830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17471	Polyester suture, bioabsorbable, multifilament, non-antimicrobial	A multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active
46241	Surgical support tape, bioabsorbable	A band or cord intended to be used during surgery for the approximation, fixation, retraction, stabilization, reinforcement, and/or suspension of internal anatomical structures. The device is typically made of a synthetic material (e.g., polyglactin, polydioxanone), is available in a variety of lengths, and may include a needle. This tape is left in situ. This is a device made of material that is chemically degraded or absorbed via natural body processes. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07757093036913	GS1	BOX	12	In Commercial Distribution
Primary	07757093001492	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100780	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify
Needle Gauge	260	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Storage Environment Temperature
• Temperature Range: 19 – 30 Degrees Celsius