Intacs Forceps

GUDID 00850048576049

Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.

ADDITION TECHNOLOGY, INC.

Dressing/utility forceps, scissors-like, reusable

• Primary Device ID: 00850048576049
• NIH Device Record Key: 0039824d-7cf8-42df-96ed-ae6c82431edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intacs Forceps
• Version Model Number: KV10445
• Company DUNS: 118496814
• Company Name: ADDITION TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850048576049 [Primary]

FDA Product Code

• HNR: Forceps, Ophthalmic

Sterilization

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

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

[00850048576049]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by ADDITION TECHNOLOGY, INC.

• 00850048576001 - Intacs Corneal Separator, CW, 0.9mm: 2023-06-21 The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each
• 00850048576018 - Intacs Corneal Separator, CCW, 0.9mm: 2023-06-21 The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each
• 00850048576025 - Intacs Inspection Gauge: 2023-06-21 The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal
• 00850048576032 - Intacs Procedure Marker: 2023-06-21 The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal
• 00850048576049 - Intacs Forceps: 2023-06-21Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
• 00850048576049 - Intacs Forceps: 2023-06-21 Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
• 00850048576056 - Intacs Vacuum Centering Guide: 2023-06-21 The Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Va
• 00850048576063 - Intacs Pocketing Hook: 2023-06-21 Designed to be used in an operating room environment by a surgeon to delaminate cornea stroma to initiate a pocket on each side
• 00850048576070 - Intacs Symmetric Glide: 2023-06-21 The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm