Sklar®

GUDID 30649111062630

SILICONE VAG DILATOR ST/4 LRG

SKLAR CORPORATION

Vaginal dilator

• Primary Device ID: 30649111062630
• NIH Device Record Key: 28177a1e-9a5e-419c-b3a4-5c400c9e9c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sklar®
• Version Model Number: 90-5264
• Company DUNS: 006966006
• Company Name: SKLAR CORPORATION
• Device Count: 4
• 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: true
• 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	06491110626305 [Unit of Use]
GS1	30649111062630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003380

FDA Product Code

• HDX: DILATOR, VAGINAL

Sterilization

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

[30649111062630]

Moist Heat or Steam Sterilization

[30649111062630]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-23

On-Brand Devices [Sklar®]

• 50649111400993: METZ SCISS CVD 5 1/2 STER CS50
• 50649111400986: METZ SCISS CVD 5 1/2 STER CS25
• 50649111400979: METZ SCISS CVD 7" STER CS25
• 50649111400962: METZEN SCISS STERILE CRV 7" 50
• 50649111400948: IRIS SCISS CRV STRL 4 1/2 100
• 50649111400931: IRIS SCISS STR STRL 4 1/2 100
• 50649111400917: MAYO-HEGAR NH 6" STERILE CS/25
• 50649111400900: MAYO-HEGAR NH 6" STERILE CS/50
• 50649111400894: DERF NH SERR 4 3/4" STERL CS25
• 50649111400887: DERF NH SERR 4 3/4" STERL CS50
• 50649111400870: TISSUE FCP 1X2 5"STERILE CS/50
• 50649111400863: DRESSING FCP SERR 5" STERL 25
• 50649111400856: DRESSING FCP SERR 5" STERL 50
• 50649111400849: HARTMANN FCP CVD 3 1/2 STRL 25
• 50649111400832: HARTMANN FCP STR 3 1/2 STRL 25
• 50649111400825: CRILE FCP CVD 5.5" STERL CS/25
• 50649111400818: CRILE FCP CVD 5.5" STERL CS/50
• 50649111400801: CRILE FCP STR 5.5" STERL CS/25
• 50649111400795: CRILE FCP STR 5.5" STERL CS/50
• 50649111400788: ROCH PEAN CVD 6 1/4 STERL CS25
• 50649111400771: ROCH PEAN FCP CVD STER 61/4 50
• 50649111400764: ROCH PEAN FCP STR STER 61/4 25
• 50649111400757: ROCH PEAN FCP STR STER 61/4 50
• 50649111400733: MAYO SCISS STR 5.5" STRL CS/25
• 50649111400726: MAYO SCISS STR 5.5" STRL CS/50
• 50649111400702: OR SCIS STR SH/SH5.5"STRLCS/50
• 50649111400696: WIRE CUT SCIS ANG 4 3/4 STRL25
• 50649111400689: WIRE CUT SCIS ANG 4 3/4 STRL50
• 50649111400672: METZ SCISS STR STER 5.5" 25/CS
• 50649111400665: METZ SCISS STR STER 5.5" CS/50
• 50649111400658: LITT SUT SCISS 5 1/2 STER CS25
• 50649111400641: LITT SUT SCIS 5 1/2 STER CS/50
• 50649111400634: SPENCER ST SCISS 3.5" STER C25
• 50649111398078: CRILE-WOOD NH 6" STERILE CS/25
• 50649111398061: CRILE-WOOD NH 6" STERILE CS/50
• 50649111398054: HALSEY NH SMOOTH 5" STERL CS25
• 50649111398047: HALSEY NH SMOOTH 5" STER CS/50
• 50649111398030: CASTRO NH 5.5"STR W/CAT CS/25
• 50649111398023: OLSEN-HEGAR NH 5.5" STRL CS/25
• 50649111398016: OLSEN-HEGAR NH 5.5" STRL CS/25
• 50649111398009: HALSEY NH SERR 5" STRL CS/25
• 50649111397996: HALSEY NH SERR 5" STRL CS/25
• 50649111361669: SKLAR DISINFECT 24OZ BTL CS/6
• 50649111359796: SKLAR KLEEN POWD 3 1/2 LB CS/6
• 50649111357679: SKLAR DISINFECTANT WIPES CS/6
• 50649111357150: SKLAR KLEEN LIQ DETR 8OZ CS/6
• 50649111328303: SKLAR SURGICAL SKIN MARKER 50
• 50649111322844: 96-1744
• 50649111303539: STERL SKLAR CERVIX BRUSH 100BX
• 50649111278899: Disposable CSR Sterilization Wrap