FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832025815
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
39LC-705-1
Catalog number
39LC-705-1
Device description
Parafree Base Molds 10 x10 mm
Published
2025-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832025815PrimaryGS10
00849832025818Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983202581510849832025815
00849832025818008498320258188498320258180849832025818

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849832028345Leica Biosystems380365538036552026-10-13
10849832018619Leica Biosystems380077038007702026-10-13
10849832020360Leica Biosystems380079038007902026-10-13
10849832022968Leica Biosystems3800840E3800840E2026-10-13
10849832024122Leica Biosystems380078038007802026-10-13
10849832024153Leica Biosystems3800780AS3800780AS2026-10-13
10849832024306Leica Biosystems380081038008102026-10-13
10849832024368Leica Biosystems3800754AS3800754AS2026-10-13
10849832026904Leica Biosystems380084038008402026-10-13
20849832020343Leica Biosystems380081027AS380081027AS2026-10-13
20849832020350Leica Biosystems3800790BLK3800790BLK2026-10-13
20849832020695Leica Biosystems3800771BLK3800771BLK2026-10-13
20849832023092Leica Biosystems380075938007592026-10-13
20849832024105Leica Biosystems380079024AS380079024AS2026-10-13
20849832024112Leica Biosystems3800754BLK3800754BLK2026-10-13
20849832024396Leica Biosystems380075432AS380075432AS2026-10-13
20849832025676Leica Biosystems380077124AS380077124AS2026-10-13
00849832023036Leica Biosystems380085038008502026-10-12
00849832023043Leica Biosystems380085438008542026-10-12
00849832023050Leica Biosystems380085238008522026-10-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816394022395Helmer ScientificHELMER, INC.LXG2026-10-14
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00816394022456Helmer ScientificHELMER, INC.LXG2026-10-14
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04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PSSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CBSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917253437Archiving CapSarstedt Aktiengesellschaft & Co.KGLXG2026-07-20
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
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10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
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00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22