MONARCH DISPO-SPEC 100CC

GUDID 00613970001016

CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE SMALL - 144/EACH PER CASE EACH IN A POLY BAG - 12/BOXES OF 12/EACH PER CASE

MONARCH MOLDING, INC.

Vaginal speculum, single-use

• Primary Device ID: 00613970001016
• NIH Device Record Key: 3b50e511-9bcc-4a97-9f4c-f5a4798ad2e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONARCH DISPO-SPEC
• Version Model Number: 100C
• Catalog Number: 100CC
• Company DUNS: 007136203
• Company Name: MONARCH MOLDING, INC.
• Device Count: 144
• 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: 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

Customer Support Contacts

• Phone: 620-767-5115
• Email: mmonarch@tctelco.net
• Phone: 620-767-5115
• Email: mmonarch@tctelco.net
• Phone: 620-767-5115
• Email: mmonarch@tctelco.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613970001016 [Primary]
GS1	10613970001013 [Unit of Use]

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-14

Devices Manufactured by MONARCH MOLDING, INC.

• 00613970001009 - MONARCH DISPOSO- SPEC: 2018-03-29 CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE SMALL 100/EACH PER CASE - 4 BAGS OF 25/EACH
• 00613970001016 - MONARCH DISPO-SPEC: 2018-03-29CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE SMALL - 144/EACH PER CASE EACH IN A POLY BAG - 12/BOXES OF 12/EACH PER CASE
• 00613970001016 - MONARCH DISPO-SPEC: 2018-03-29 CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE SMALL - 144/EACH PER CASE EACH IN A POLY BAG - 12/BOXES OF 12/EACH PER C
• 00613970002006 - MONARCH DISPOSO-SPEC: 2018-03-29 CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE MEDIUM 100/EACH PER CASE 4 BAGS OF 25/EACH
• 00613970002013 - MONARCH DISPOSO-SPEC: 2018-03-29 CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE - MEDIUM - 100 EACH PER CASE 20 - BAGS OF 5/EACH PER BAG
• 00613970002020 - MONARCH DISPOSO-SPEC: 2018-03-29 CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE MEDIUM - 144 PER CASE EACH IN A POLY BAG - 12/BOXES OF 12/EACH PER CASE
• 00613970003003 - MONARCH DISPOSO-SPEC: 2018-03-29 ONE TIME USE (LARGE) WHITE PLASTIC DISPOSABLE VAGINAL SPECULUM 100/EACH PER CASE- 4/BAGS OF 25 EACH
• 00613970014856 - MONARCH DISPOSABLE ANOSCOPE: 2018-03-29 ONE TIME USE 14mm x 85mm (CLEAR) PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE- 2/BAGS OF 50 EACH
• 00613970018908 - MONARCH DISPOSABLE ANOSCOPE: 2018-03-29 ONE TIME USE 18mm x 90mm (CLEAR) PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE-2/BAGS OF 50 EACH