HER-SPEC

GUDID M648C0205202

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE

OBP CORPORATION

Vaginal speculum, single-use

• Primary Device ID: M648C0205202
• NIH Device Record Key: 18c55abb-27f6-4fd0-92d0-369cbf10e3e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HER-SPEC
• Version Model Number: C020520
• Company DUNS: 011560431
• Company Name: OBP CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M648C0205200 [Primary]
HIBCC	M648C0205201 [Package]; Contains: M648C0205200; Package: BOX [14 Units]; In Commercial Distribution
HIBCC	M648C0205202 [Package]; Contains: M648C0205201; Package: CASE [56 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-31
• Device Publish Date: 2019-10-23

On-Brand Devices [HER-SPEC]

• M648C0206202: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE - STERILE
• M648C0206102: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM - STERILE
• M648C0206002: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL - STERILE
• M648C0205202: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE
• M648C0205102: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM
• M648C0205002: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL