SynFrame 387395

GUDID 07611819099524

SYNFRAME RETRACTOR 140MM

Synthes GmbH

Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable

• Primary Device ID: 07611819099524
• NIH Device Record Key: 5f9c9a35-7e5c-4354-aa7a-0313ce2450d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynFrame
• Version Model Number: 387.395
• Catalog Number: 387395
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819099524 [Direct Marking]
GS1	10705034771243 [Primary]
HIBCC	H9813873950 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993314

FDA Product Code

• FQP: Lamp, operating-room

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

[07611819099524]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-04-27
• Device Publish Date: 2016-06-30

On-Brand Devices [SynFrame]

• 07611819813731: SYNFRAME FLEX ARM BRIDGE
• H981SD3873600: SYNFRAME GUIDE ROD WITH CLAMP
• H981SD3873590: SYNFRAME GUIDE ROD-SHORT
• H981SD3873580: SYNFRAME GUIDE ROD-RIGID
• H981SD3873570: SYNFRAME GUIDE ROD- 50 DEG ANGLE
• H981SD3873560: HOLDER FOR SYNFRAME BONE LEVERS-SHORT
• H981SD3873470: SYNFRAME RING CLAMP-REVERSED
• H981SD3873460: ADAPTER FOR SYNFRAME
• H981SD3873610: SYNFRAME GUIDE ROD LONG
• 07611819110144: SYNFRAME BONE LEVER- 18MM WIDTH/150MM
• 07611819110137: SYNFRAME BONE LEVER- 18MM WIDTH/130MM
• 07611819110120: SYNFRAME BONE LEVER- 8MM WIDTH/160MM
• 07611819110113: SYNFRAME BONE LEVER- 8MM WIDTH/130MM
• 07611819110106: SYNFRAME BONE LEVER- 8MM WIDTH/100MM
• 07611819113169: SYNFRAME RIB RETRACTOR- 40MM WIDTH/50MM
• 07611819113152: SYNFRAME RIB RETRACTOR- 30MM WIDTH/40MM
• H9813874370: SYNFRAME RETRACTOR- 50MM WIDTH/180MM
• 07611819759381: SYNFRAME RETRACTOR- 50MM WIDTH/160MM
• 07611819759374: SYNFRAME RETRACTOR- 50MM WIDTH/140MM
• H9813874340: SYNFRAME RETRACTOR- 50MM WIDTH/120MM
• H9813874330: SYNFRAME RETRACTOR- 50MM WIDTH/100MM
• H9813874320: SYNFRAME RETRACTOR- 23MM WIDTH/220MM
• H9813874310: SYNFRAME RETRACTOR- 23MM WIDTH/200MM
• 07611819099524: SYNFRAME RETRACTOR 140MM
• 07611819238992: SYNFRAME RETRACTOR HOLDER- ADJUSTABLE
• 07611819099005: SYNFRAME GUIDE ROD
• 07611819110175: HOLDER FOR SYNFRAME BONE LEVERS
• 07611819098985: SYNFRAME TUBE-TO-TUBE CLAMP
• 07611819141278: SYNFRAME RING CLAMP
• 07611819141261: SYNFRAME INSULATED TABLE CLAMP
• 07611819098954: SYNFRAME CONNECTING ROD
• 07611819098947: SYNFRAME ANGLED ROD
• 07611819098930: SYNFRAME ANGLED ROD HOLDER
• 07611819109230: SYNFRAME LENGTHENER
• 07611819109216: SYNFRAME HALF RING
• 07611819109223: SYNFRAME HOLDING RING TWO-PIECE
• 07611819255913: SYNFRAME HOLDING RING-SMALL 2 PIECE-240MM DIAMETER
• 07611819255906: SYNFRAME EXTENSION-ADJUSTABLE