FDA.reportPublic FDA data

CROC Series Endoscopic Device

Primary DI
40666416140082
Brand
CROC Series Endoscopic Device
Company
Primed Instruments Inc
Model
H628S
Catalog number
H628S
Device description
High capacity single-use biopsy forceps with serrated jaws, needle and ezSlide® sheath. HIBC/UPN: M453H628S3
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40666416140082PrimaryGS10
00666416140084Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4066641614008240666416140082
00666416140084006664161400846664161400840666416140084

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Biopsy forceps should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Case contains 8 dispenser boxes. Each dispenser box contains 20 devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-565-0565info@primedinstruments.com

Regulatory Flags#

DUNS number
254491293
Device count
160
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0066641611231980000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
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00666416120925SuperDART® ONE PASS™ Validated Channel Cleaning Kit91449144-252025-06-13
00666416121144SuperDART® ONE PASS™ Validated Channel Cleaning Device92539253-252025-06-13
00666416121274SuperDART® ONE PASS™ Validated Channel Cleaning Kit93559355-252025-06-13
00666416121298SuperDART® ONE PASS™ Validated Channel Cleaning Device92939293-252025-06-13
00666416121311SuperDART® ONE PASS™ Validated Channel Cleaning Kit93999399-252025-06-13
00666416121335SuperDART® ONE PASS™ Validated Channel Cleaning Device92339233-252025-06-13
00666416121359SuperDART® ONE PASS™ Validated Channel Cleaning Kit93339333-252025-06-13
006664161214589000 Series Disposable Channel Cleaning Brush050338800405033880042025-06-13
006664161217319000 Series Disposable Channel Cleaning Brush050338800405033880042025-06-13
006664161217489000 Series Disposable Channel Cleaning Brush050338800205033880022025-06-13
1066641611231680000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
0066641611065080000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
00666416120918SuperDART® ONE PASS™ Validated Channel Cleaning Kit91449144-252025-06-13
00666416121137SuperDART® ONE PASS™ Validated Channel Cleaning Device92539253-252025-06-13
00666416121267SuperDART® ONE PASS™ Validated Channel Cleaning Kit93559355-252025-06-13
00666416121281SuperDART® ONE PASS™ Validated Channel Cleaning Device92939293-252025-06-13
00666416121304SuperDART® ONE PASS™ Validated Channel Cleaning Kit93999399-252025-06-13
00666416121328SuperDART® ONE PASS™ Validated Channel Cleaning Device92339233-252025-06-13

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Primary DI, Brand, Company table
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