ER-SPEC/OFFICE-SPEC

Basic Information

• Brand Name: ER-SPEC/OFFICE-SPEC
• Primary DI: M648C0203000
• Version / Model: C020300
• Catalog Number: C020300
• Company Name: OBP CORPORATION
• Labeler DUNS: 011560431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5e8987b1-6d59-4b6b-9fdc-77cfeca27543

Device Description

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL - STERILE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M648C0201202	HIBCC	CASE	4	In Commercial Distribution
Package	M648C0203001	HIBCC	BOX	12	In Commercial Distribution
Primary	M648C0203000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K091937	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 45 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius